(201 days)
The EMS Nasal CPAP mask and accessories (mask, spacers, mask support ring and headgear) are used with and attached to a positive pressure air source, CPAP or Bi-level equipment, and has the Indications for Use consistent with the Indications for Use of the equipment to which it is attached.
Environment of use: Hospital, sleep laboratories or home
The EMS Nasal CPAP mask is a mask covering the nose of a patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose. It connects to a patient circuit which contains an exhalation device, tubing and perhaps a humidifier and/or bacteria filter. It is held in place with an adjustable headgear system. It made to be cleaned by soap and water.
There are optional accessories which may assist in providing more patient comfort - Foam Spacers help to reduce excessive headgear tension and relieve pressure on the bridge of the nose and Cushion Support Ring which supports the wall of the cushion.
The provided documentation for the "EMS Nasal CPAP Mask and Accessories" does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the "Respironics Silicone Contour Nasal CPAP mask (K883825)," by comparing various attributes.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as no such performance study is presented.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria (e.g., in terms of sealing performance, pressure delivery, comfort levels against a defined standard) or corresponding reported performance metrics for the EMS Nasal CPAP Mask are provided in this submission beyond a direct comparison of features and intended use with a predicate device. The document primarily focuses on a qualitative comparison to establish substantial equivalence.
The table in the original document outlines the comparison between the EMS Nasal CPAP and the predicate device. It implies that meeting the predicate's established characteristics serves as an "acceptance" for substantial equivalence.
| Attribute | EMS/Nasal CPAP | Respironics Contour Nasal Mask K883825 | Acceptance (Implied for Substantial Equivalence) |
|---|---|---|---|
| Same indications as equipment to which it is attached such as CPAP and Bi-level devices | Yes | Yes | Yes |
| Used on adults with OSA | Yes | Yes | Yes |
| Intended to be single patient - multi-use | Yes | Yes | Yes |
| Environment Home and Hospital | Yes | Yes | Yes |
| Same dimensions as the predicate | Yes | Yes | Yes |
| Offered in multiple sizes | Yes | Yes | Yes |
| Intended to be cleaned | Yes | Yes | Yes |
| Adapts to headgear | Yes | Yes | Yes |
| Separate Exhalation port / device required | Yes | Yes | Yes |
| Compatible with 22 mm tubing | Yes | Yes | Yes |
| Optional Foam Spacers | Yes | Yes | Yes |
| Optional Cushion Support Ring | Yes | Yes | Yes |
| Cushion made of silicone | Yes | Yes | Yes |
| Cone and swivel elbow made of Polycarbonate | Yes | Yes | Yes |
| Exact materials as utilized in the predicate devices | Yes | Yes | Yes |
| Performance Standards / Specifications (None required under Section 514) | Yes | Yes | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. No performance study with a test set composed of patient data is described. The comparison is based on device specifications and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of a performance study involving patient data or expert assessment, is not established or discussed in this document.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No. The document describes a comparison of device attributes for substantial equivalence, not an MRMC study assessing human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (CPAP mask), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of a diagnostic or therapeutic performance study. The "ground truth" for this submission is implicitly the established characteristics and performance of the legally marketed predicate device (Respironics Silicone Contour Nasal CPAP mask K883825) against which the new device is being compared for substantial equivalence.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set with established ground truth.
In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence to a predicate device by comparing design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).